Contents1. Economics of gene patents
for diagnostic testing under scrutiny2. Men redundant? Now we
don't need women either3. Mouse cell transplants
for Huntington's patients4. Australian Company Suspected
of Human Bio-Piracy

1.Economics of gene patents for diagnostic testing under
scrutiny

Tom Abate <mailto:tabate@sfchronicle.com>

Monday, February 11, 2002

San Francisco ChronicleDiagnostic tests based on newly discovered genes could
be the first medicaland investment payoff of the genome age.But will the same gene patents that encourage research
restrict access bypricing new procedures out of reach?A small but growing chorus of critics is beginning to
suggest just that,most recently in a Feb. 7 article in the journal Nature."Gene patents affect the cost and availability of clinical-diagnostictesting," wrote the authors, which included Stanford
University bioethicistMildred Cho.In addition to the most recent Nature study, which looked
at a testcontrolled by Bio-Rad in Hercules, Cho has conducted
broader surveyssuggesting that nearly half of all diagnostic labs have
been forced to quitdoing certain tests because of gene patents.Questioning gene patents hits at the foundations of biotechnology.
When theindustry was born a quarter century ago it wasn't clear
that genediscoveries could get the same patent protection as new
chemical drugs -- orbetter mouse traps.But a 5-4 Supreme Court ruling in June 1980 paved the
way for gene patents.A few months later Genentech floated the first biotech
IPO. Ever since, genepatents and biotechnology have been as American as the
flag and apple pie.Some would like to turn back the clock and make genes,
proteins and celllines unpatentable. "These things evolved biologically,
it isn't in thepublic interest to turn them into private property,"
said Jonathan King, ascientist at MIT and member of the Council for Responsible
Genetics, anonprofit group in Cambridge, Mass.The biotech industry thinks the opposite. The diagnostics
sector isexperiencing a boom, in part because patented new gene
tests are expected tocommand higher prices than the generic tests of the past.But spats over the restrictions or costs imposed on gene
tests have focusedattention on the patent issue.Ashkenazi Jewish families have charged that patents inflate
the costs oftests for inherited conditions like Canavan disease (a
cripplingneurological disorder) common in that community.A test for breast and ovarian cancer has been another
flash point. MyriadGenetics of Salt Lake City holds patents on BRCA1 and
BRCA2, genes that seemto be tumor suppressors. Myriad has created tests to
detect mutations inthese genes that increase the chances of developing these
cancers.Myriad sells its most complete test for $2,680. Researchers
at France'sCurie Institute have challenged Myriad's patents in Europe,
claiming theyare overly broad and prevent them from doing less costly
tests. Healthministers in Ontario, Canada, have instructed hospitals
in that province toignore Myriad's patents and continue conducting their
own cheaper tests.Myriad spokesman William Hockett said Myriad's test is
far more precise thanany other procedure, and can detect more than 500 different
mutations in thegenes. Such precision has required an investment in DNA
sequencingequipment, computers and research going back to 1994."This technology is very sophisticated," Hockett said,
adding that Myriadcouldn't charge significantly less for the test "unless
somebody wassubsidizing it."Paul Billings, a geneticist with the San Francisco consulting
firm GeneSage,said the biotech industry will have to set prices at
levels "that don'tprovoke a public revolt" against the gene patents upon
which the industrydepends.Meanwhile, the broader issue of gene patents and their
narrower applicationto diagnostic tests appear to have caught the attention
of at least onelawmaker on Capitol Hill.Rep. Lynn Rivers (D-Mich.) has been circulating drafts
of two bills she isconsidering introducing. One would instruct the federal
Office of Scienceand Technology Policy to study whether gene patents are
aiding or hinderingresearch.The second bill would prevent companies from enforcing
gene patents ondiagnostic tests. A staffer says Rivers is still taking
comments and hasn'tdecided whether to introduce either, both or neither
bill.TB BREAKTHROUGH?: Chiron Corp. signed an innovative deal
last week thatcould set a pattern for how corporations and nonprofits
can work together todevelop medicines for Third World diseases.The Emeryville biotech firm gave New York's Global Alliance
for TB DrugDevelopment the rights to develop a promising experimental
compound callednitroimidazopan. It's been 30 years since there's been
a new anti-TB drugand scientists have high hopes that the Chiron compound
will be abreakthrough.The Alliance has upwards of $40 million in funding from
the RockefellerFoundation, the Gates Foundation and other sources. It
will use those fundsto carry out animal tests and, if all goes well, human
clinical trials ofthe anti-TB drug. If it works, the Alliance will be free
to sell the drug,without any patent restriction or royalty fees, in Third
World nations whereTB kills 2 million people a year.Chiron wins something in return. If the Alliance proves
the anti-TB medicinesafe and effective, Chiron can buy back the rights to
sell a higher pricedversion in the developed world. The Alliance will still
be free to sell thecheap version abroad."It's one of those rare win-win situations," said Craig
Wheeler, presidentof Chiron's biopharmaceutical division.He explained how the deal came about. The anti-TB drug
was one of theexperimental compounds that Chiron obtained when it acquired
the Seattlebiotech firm PathoGenesis in August 2000. Chiron decided
the TB marketwasn't large enough, in dollar terms, to warrant the
costs of clinicaldevelopment and decided to see if some other firm wanted
to buy the rights.About this time the Alliance contacted Chiron and expressed
interest indeveloping the drug. The Alliance is a story in itself.
It is one of ahandful of nonprofits that have arisen in recent years
in an attempt to dowhat the market system can't -- develop cheap medicines
for the Third World.The Alliance is overseen by a board that includes health
officials from theUnited States and South Africa, a past president of Medecins
SansFrontieres, and drug industry executives, including Chiron
CEO Sean Lance.The Alliance recently hired former National Institutes
of Health officialDr. Maria Freire to run the operation. Rather than build
a drug developmentcompany, the Alliance will contract out the clinical
work.Development of the anti-TB drug is at a very early stage.
It will be acouple of years before the Alliance finishes the preclinical
studies thatwould be a prelude to human trials. And the drug could
fail at any stage, ashappens all the time.So while it's a bit early to celebrate, I find this deal
incrediblyuplifting. The free market is a powerful mechanism but
it has one and onlyone end -- the production of profits. It depresses me
to think of all theother needs that get ignored because of the market's
single-minded focus.What a deal like this tells me is that biotech leaders,
international healthofficials and philanthropic groups are trying to create
mechanisms toaddress needs that would otherwise fall through the cracks.I'm keeping my fingers crossed, both for the TB drug
and the largerexperiment in nonprofit drug development.

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2.Men redundant? Now we don't need women eitherScientists have developed an artificial womb that allows
embryos to growoutside the body

Doctors are developing artificial wombs in which embryos
can grow outside awoman's body. The work has been hailed as a breakthrough
in treating thechildless.Scientists have created prototypes made out of cells
extracted from women'sbodies. Embryos successfully attached themselves to the
walls of theselaboratory wombs and began to grow. However, experiments
had to beterminated after a few days to comply with in-vitro fertilisation
(IVF)regulations.'We hope to create complete artificial wombs using these
techniques in a fewyears,' said Dr Hung-Ching Liu of Cornell University's
Centre forReproductive Medicine and Infertility. 'Women with damaged
uteruses andwombs will be able to have babies for the first time.'The pace of progress in the field has startled experts.
Artificial wombscould end many women's childbirth problems - but they
also raise majorethical headaches which will be debated at a major international
conferencetitled 'The End of Natural Motherhood?' in Oklahoma next
week.'There are going to be real problems,' said organiser
Dr Scott Gelfand, ofOklahoma State University. 'Some feminists even say artificial
wombs meanmen could eliminate women from the planet and still perpetuate
our species.That's a bit alarmist. Nevertheless, this subject clearly
raises strongfeelings.'Liu's work involves removing cells from the endometrium,
the lining of thewomb. 'We have learnt how to grow these cells in the
laboratory usinghormones and growth factors,' she said.After this Liu and her colleagues grew layers of these
cells on scaffolds ofbiodegradable material which had been modelled into shapes
mirroring theinterior of the uterus. The cells grew into tissue and
the scaffolddissolved. Then nutrients and hormones such as oestrogen
were added to thetissue.'Finally, we took embryos left over from IVF programmes
and put these intoour laboratory engineered tissue. The embryos attached
themselves to thewalls of our prototype wombs and began to settle there.'The experiments were halted after six days. However,
Liu now plans tocontinue with this research and allow embryos to grow
in the artificialwombs for 14 days, the maximum permitted by IVF legislation.
'We will thensee if the embryos put down roots and veins into our
artificial wombs'walls, and see if their cells differentiate into primitive
organs anddevelop a primitive placenta.'The immediate aim of this work is to help women whose
damaged wombs preventthem from conceiving. An artificial womb would be made
from their ownendometrium cells, an embryo placed inside it, and allowed
to settle andgrow before the whole package is placed back in her body.'The new womb would be made of the woman's own cells.
so there would be nodanger of organ rejection,' Liu added.However, her research is currently limited by IVF legislation.
'The nextstage will involve experiments with mice or dogs. If
that works, we shallask to take our work beyond the 14-day limit now imposed
on such research.'A different approach has been taken by Yoshinori Kuwabara
at JuntendoUniversity in Tokyo. His team has removed foetuses from
goats and placedthem in clear plastic tanks filled with amniotic fluid
stabilised at bodytemperature. In this way, Kuwabara has kept goat foetuses
alive and growingfor up to 10 days by connecting their umbilical cords
to machines that pumpin nutrients and dispose of waste.While Liu's work is aimed at helping those having difficulty
conceiving,Kuwabara's is designed to help women who suffer miscarriages
or verypremature births. In this way Liu is extending the time
an embryo can existin a laboratory before being placed in a woman's body;
Kuwabara is trying togive a foetus a safe home if expelled too early from
its natural womb.Crucially, both believe artificial wombs capable of sustaining
a child fornine months will become reality in a few years.'Essentially research is moving towards the same goal
but from oppositedirections,' UK fertility expert Dr Simon Fishel, of
Park Hospital,Nottingham, said. 'Getting them to meet in the middle
will not be easy,however. There are so many critical stages of pregnancy,
and so many factorsto get right. Nevertheless, this work is very exciting.'It also has serious ethical implications, as Gelfand
pointed out. 'For astart, there is the issue of abortion. A woman is usually
allowed to haveone on the grounds she wants to get rid of something
alien inside her ownbody.'At present, this means killing the foetus. But if artificial
wombs aredeveloped, the foetus could be placed in one, and the
woman told she has tolook after it once it has developed into a child.'In addition, if combined with cloning technology, artificial
wombs raise theprospect that gay couples could give 'birth' to their
own children. 'Thiswould no doubt horrify right-wingers, while the implications
for abortionlaw might well please them,' he added.Gelfand also warned that artificial wombs could have
unexpected consequencesfor working women and health insurance. 'They would mean
that women would nolonger need maternity leave - which employers could become
increasinglyreluctant to give.'It may also turn out that artificial wombs provide safer
environments thannatural wombs which can be invaded by drugs and alcohol
from a mother'sbody. Health insurance companies could actually insist
that women opt forthe artificial way.'Certainly, this is going to raise a lot of tricky problems.'

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3.

Mouse cell transplants for Huntington's patients

16:15 11 February 02Emma YoungNew Scientists

Transplants of mouse stem cells into the brains of patients
withHuntington's Chorea could help slow the associated dementia
and loss ofcoordination, says UK company ReNeuron. It hopes to start
clinical trials ofthe technique in the US early in 2003.Huntington's is caused by an inherited genetic mutation,
which leads to adestruction of cells in a part of the brain called the
striatum. ReNeuronhas transplanted cells from its mouse neural stem cell
line into monkeysdesigned to act as models of Huntington's patients."We have shown the cell line will transplant into the
monkey brain - andthat it will restore function," says John Sinden, ReNeuron's
chiefscientist.ReNeuron is developing a line of human neural stem cells
for use intransplantation experiments. But the mouse cell line
could be ready for usein people much earlier - by autumn 2002, says Sinden.
Then, he says, thecompany will make a formal application to the US Food
and DrugAdministration to begin the trial. Regulations governingxenotransplantation - the transplantation of cells from
one species toanother - are less strict in the US than in the UK.There are theoretical concerns that potentially deadly
viruses from thedonor animal cells could be passed to the human recipients.
But Sindenthinks this will be unlikely in the case of the mouse
cells.

Fetal tissueThe potential benefits outweigh the risks, he says. "We
wouldn't seek totake a xenotransplantation product into a large population
of patients withAlzheimer's, for example. But where you've got a very,
very seriouscondition with a relatively small number of patients
that can only getworse, and you've got something that you know works,
I think it makes senseto give it a shot."Rejection of the mouse cells should not be a problem
in the brain, where theimmune system is less active than in the rest of the
body.Other groups of researchers are transplanting fetal tissue
into the brainsof Huntington's patients. One group, in Paris, has reported
some success.But, as Sinden points out, the number of aborted fetuses
available formedical use is limited. "This procedure can only be used
in an experimentalway in a small number of patients," he says.In theory, an unlimited number of cells for treatment
could be generatedfrom the mouse, and from the human, stem cell lines.
At the moment,ReNeuron's human line is too genetically unstable, with
unpredictablechromosomal abnormalities appearing as the cells repeatedly
divide, saysSinden. The team is now adding a gene to protect the
chromosomes. "Webelieve we will get a genetically stable line, but it
will take us sometime," he says.The UK's Huntington's Disease Association cautiously
welcomes ReNeuron'splans. "Obviously it's very early days. And as there
are no conclusiveresults to date on the use of fetal cells, I'd hesitate
to say we'repositive about any trials," says a spokeswoman.

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4.12 Feb 2002MEDIA RELEASE

Australian Company Suspected of Human Bio-Piracy

Tongan Human Rights Activists to Address Adelaide Conference

Tongan human rights activists have condemned an agreement
between theTongan government and an Australian biotech company,
Autogen Ltd., tocollect blood samples from the Tongan people. The
reported agreement wasconcluded without any public debate and opens the way
for thecommercialisation and patenting of the genetic material
of indigenouspeoples.

The current status of the agreement is unclear.
According to the Directorof the Tonga Human Rights and Democracy Movement, Lopeti
Senituli, lI wasinformed by Tonga Heath officials last year that no agreement
was signedwith Autogen but we have good reason to suspect that
Autogen Ltd could betrying to circumvent the Tongan publicms scrutiny by
disguising its geneticresearch proposal as a public health programme funded
by the Australiangovernment.n

Mr. Senituli is scheduled to present a paper on the issue
at theAustralasian Bioethics Association Conference in Adelaide
on 14 February.The paper will be jointly presented with Margaret Boyes
of Sydney.

Mr. Senituli said, lThe Tongan people believe that
God is the Creator ofall living things and therefore all lifeforms should
be treated in a waythat respects their intrinsic value as living generational
manifestationsof Creation. The conversion of human lifeforms,
their molecules or partsinto corporate property, as Autogen is proposing is in
direct conflict withour belief in the sanctity of human life.n

He also said that the Autogen proposal is the latest phase
in thecolonization of the indigenous peoples of the Pacific
and their resources.lThree centuries ago they came for sandalwood.
Today the bastards areafter our genes.n

Ends

For further information contact Margaret Boyes

Until 2pm Wed 13/2/02 Sydney on ph. (02) 9568-4348

>From 7pm Wed 13/2/02 on 0408-818-012

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